Whiteside Acrylic Cement Spacer Sleeve
FDA 510(k) K844637 · Dow Corning Corp. Healthcare Industries Materials
510(k) numberK844637
Submission
- Device name
- Whiteside Acrylic Cement Spacer Sleeve
- Applicant
- Dow Corning Corp. Healthcare Industries Materials
P.O. Box 1767 Midland, MI, US - Received
- November 28, 1984
- Decision date
- June 19, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LTC – Hyaline Membrane Disease Assay
- Device class
- Class III (high risk)
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Questions and answers
When was Whiteside Acrylic Cement Spacer Sleeve cleared by the FDA?
Whiteside Acrylic Cement Spacer Sleeve (K844637) received a 510(k) decision of Substantially Equivalent on June 19, 1985, 203 days after the submission was received.
What is the product code of K844637?
The FDA product code is LTC – Hyaline Membrane Disease Assay, a Class III (high risk) device.